Field of the Invention
The present invention relates to surgical devices, such as ophthalmic surgical devices, and, more particularly relates to a device, system and method for inserting an intraocular lens (IOL) into an eye.
Description of the Background
An IOL is an artificial lens implanted to replace or supplement the natural crystalline lens of an eye due to poor or non-functionality of the natural lens. For example, such poor or non-functionality may occur when the natural lens develops cataracts or is otherwise diseased, by way of non-limiting example, and in such cases the natural lens may be removed from the eye and replaced by an IOL. Such poor or non-functionality may also occur due to refractive errors of the eye, and, for such refractive errors, the natural lens may remain in the eye together with an implanted IOL in order to provide optimal vision.
An IOL may be implanted in the posterior chamber or anterior chamber of the eye. IOLs may be provided in a variety of configurations, for a variety of purposes, and formed of any of numerous available materials. IOLs often include an optic, which typically includes an optically clear lens, and preferably at least one flexible fixation member, or haptic, which extends from the optic and becomes affixed in the eye to secure the IOL in position. For example, common IOLs include open-looped haptics, which include a three-piece IOL having an optic and two haptics attached to and extending from the optic, and a one-piece IOL in which the optic and haptics are integrally formed, and closed looped haptic IOLs. Further, in a plate haptic IOL, the haptics are configured as a flat plate extending from opposite sides of the optic. An IOL may be formed from, by way of non-limiting PMMA, silicone, hydrogels, silicone hydrogels, and combinations thereof.
There exists a number of instruments and methods for implanting an IOL. For example, surgical forceps having opposing blades may be used to grasp the IOL and insert it through an incision. However, this method is deemed relatively crude, and thus, ever more commonly, sophisticated IOL inserter devices are in use. IOL inserter devices offer increased control when inserting the IOL, and decreased need for larger incisions due to reduced diameter insertion tips. It goes without saying that smaller incision sizes, on the order of or less than about 3 mm, allow for reduced post-surgical healing time and fewer complications. However, despite these significant advantages provided by modern IOL inserter devices, lack of sufficient control, particularly at the very point of IOL insertion, still often causes the IOL to “pop” from the inserter device, thereby causing misplacement of the IOL, particularly in view of the decreased maneuverability granted a surgeon due to the decreased incision size typical in IOL inserter device environments.
Further, because IOLs are delicate, great care must be taken in properly handling and precisely inserting an IOL. As referenced, due largely to smaller incision sizes, IOLs are generally folded prior to insertion, and are to assume the correct shape for optimal performance following proper insertion. As such, smooth passage of the IOL from the inserter device to the proper in-situ location is highly desirable to allow for the decompression of the IOL in-situ for optimal performance. Moreover, insertion of the IOL in such a manner so as not to damage the delicate IOL is also highly desirable. A misplaced, improperly oriented, or damaged IOL will likely require manipulation in-situ or removal of the inserted IOL and subsequent insertion of a replacement IOL. This may lead to surrounding tissue damage, or, worse yet, a secondary surgery. For these and other reasons, the aforementioned “popping” of the IOL from the inserter device, due to a lack of control over the inserter at the very point of insertion, is a very detrimental and disadvantageous occurrence.
Therefore, an IOL inserter that permits easy passage of the IOL therethrough, with a great degree of control at the insertion point, and that inserts the IOL into the eye in a predictable and repeatable orientation and manner, would be highly advantageous. Ideally, such an IOL inserter would avoid expulsion from the IOL inserter too quickly, in the wrong location, in the wrong orientation, or in an otherwise unexpected manner (i.e., “popping”), thereby avoiding the need to manipulate the IOL after insertion or to perform a secondary surgery.
In a typical IOL inserter device, a syringe-style plunger is used. The IOL is generally loaded into a closed chamber in a portion of a tapered lumen, i.e., at the lumen portion below the plunger base and toward the inserting tip. At the time of insertion, the plunger is actuated downward through the lumen toward the inserting tip of the IOL inserter, i.e., the plunger forces the IOL through the narrowing lumen toward the tip, thereby increasing the compression on the IOL, and hence the counter-pressure on the plunger. The injecting tip of the lumen is typically sized for insertion into the small surgical incision in the eye, which, as stated above, is presently preferred to be about 3 mm or less. Eventually, the displacement stemming from actuation of the plunger is sufficient to expel the IOL from the inserting tip into the eye, and the IOL unfolds, or decompresses, in-situ. Accordingly, at the point of insertion, the IOL has been compressed to at least the sub 3 mm size of the inserting tip, with a correspondent counter-pressure having built at the point of injection due to the increased compression.
The aforementioned counter-pressure to the actuation of the plunger is what frequently causes the “popping” of the IOL into the eye. As such, refined control of the displacement force at the point of insertion is of the utmost importance to prevent damage to the IOL, or misplacement or improper orientation of the IOL, due to this “popping.” However, in spite of the urgent need to remedy the issue of “popping” of the IOL from the inserting tip, this problem remains largely unaddressed in the known art.
Therefore, the need exists for an IOL inserter device, system and method that provides for insertion of an IOL into an eye in a predictable and repeatable orientation and manner, and that accordingly remedies counter-pressure at the point of IOL insertion.